Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#

K-Number: K093719 · 2010-03-01

ApplicantOsteogenics Biomedical, Inc.
Decision Date2010-03-01
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# is the device name listed in this FDA 510(k) record. The listed applicant is Osteogenics Biomedical, Inc.. It received FDA 510(k) clearance on 2010-03-01 under 510(k) number K093719. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#?

PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# is a medical device that received FDA 510(k) clearance on 2010-03-01. The listed applicant is Osteogenics Biomedical, Inc.. The 510(k) number is K093719.

When did PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# receive FDA 510(k) clearance?

PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# received FDA 510(k) clearance on 2010-03-01, under 510(k) number K093719.

Who is the listed applicant for PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#?

The FDA 510(k) record lists Osteogenics Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#?

The FDA product code for PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# is DZL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Osteogenics Biomedical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201187Cytoplast Titanium-Reinforced PTFE MembranesK171774RPM Reinforced PTFE MeshK072076CYTOPLAST PTFE SUTUREK013764IMMIX BONE GRAFT EXTENDERK003028CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HCK993610CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250

View all 8 devices →

Related Devices (Code: DZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254286Guided Bone Regeneration SystemDentalMaster(Xiamen)Medical Technology Co., Ltd.K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbHK251569Bone ScrewOsstem Implant Co., Ltd.K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KGK233419GBR SystemProimtech Saglik Urunleri Anonim SirketiK240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑